MAUDE Adverse Event Report: LENA CUP LENA CUP

Model Number	LENA-RED-S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Abnormal Vaginal Discharge (2123)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User reported having yeast infections for three months around her period and visited her doctor for medication.

• Brand Name: LENA CUP
• Common Device Name: LENA CUP
• Manufacturer (Section D): LENA CUP; 3540 highway 52; frederick CO 80516
• Manufacturer (Section G): LENA CUP; 3540 highway 52; suite h12; frederick CO 80516
• Manufacturer Contact: lachlan thom ; 3540 highway 52; suite h12; frederick, CO 80516
• MDR Report Key: 15495362
• Report Number: 3011390138-2022-00005
• Device Sequence Number: 17598576
• Product Code: HHE
• UDI-Device Identifier: 00850008236006
• UDI-Public: 00850008236006
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: LENA-RED-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown